BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE SG

    MDR report key: 8570429 · Received May 1, 2019

    Report

    Report Number
    2124215-2019-08188
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    January 29, 2019
    Report Date
    May 1, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526531248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. BASIC ISOMETRICS WERE PERFORMED WITH NO OBVIOUS ISSUES NOTED. THE PATIENT IS BEING MONITORED REMOTELY. TECHNICAL SERVICES WAS CONTACTED FOR A TREND REVIEW AND NOTED THAT THE VALUES HAVE BEEN ELEVATED ABOVE 100 OHMS, DURING THE PAST YEAR AND WERE GRADUALLY APPROACHING THE 130 OMHS MARK. TS AGREED WITH THE GUIDANCE OF CONTINUED REMOTE MONITORING AND FURTHER STATED NO OBVIOUS INDICATION OF A COMPROMISED LEAD INTEGRITY WERE EXHIBITED. THE STORED ELECTROGRAMS WERE CLEAN AND FREE OF NOISE/ARTIFACT AND ALL OTHER DIAGNOSTICS, NORMAL. NO RESULTING ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AND TO DATE, NO SYSTEM CHANGES REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364774 ENDOTAK RELIANCE SG PERMANENT DEFIBRILLATOR ELECTRODES NVY BOSTON SCIENTIFIC CORPORATION 0292 112520 00802526531248

    Patients

    Seq Age Sex Outcome Treatment
    1